Supplier Quality Engineer

TechDigital Group; Mounds View (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading technology company is seeking a highly skilled Supplier Quality Engineer in Mounds View, Minnesota. The candidate should have a strong background in medical device supplier quality, managing supplier qualifications, and executing PPAP documentation. Responsibilities include defining inspection requirements, collaborating with teams, and supporting quality assurance practices. The ideal candidate will possess a Bachelor’s degree, 4+ years of experience in the field, and familiarity with FDA and ISO standards.

Qualifications

• Minimum 4+ years of experience in supplier quality engineering within the medical device industry.
• Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans.
• Familiarity with FDA and ISO 13485 standards.

Responsibilities

• Qualify suppliers in accordance with company standards.
• Manage and release all PPAP deliverables.
• Define Receiving Inspection requirements.
• Work with cross-functional teams to implement product acceptance strategies.
• Provide technical assistance to suppliers throughout the qualification lifecycle.

Skills

Supplier quality engineering

Process validation

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Engineering or related field

Tools

PPAP

ISO 13485

PFMEA

MSA

Job description

Overview

Mandatory : ISO 13485 Certified

We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualification, PPAP documentation, and process validation. This role is critical in ensuring that suppliers meet Healthcare's quality standards and regulatory requirements.

Responsibilities

• Supplier Qualification & Management:
  • Qualify suppliers in accordance with company standards.
  • Manage and maintain the Approved Supplier List (ASL) in compliance with Healthcare's purchasing control procedures.
• PPAP Documentation & Execution:
  • Manage and release all PPAP deliverables including Control Plans, MSA, PFMEA, FAI, etc., within the document control system.
  • Support PPAP execution with suppliers and ensure robust process qualification/validation using IQ, OQ, and PQ methodologies.
• Inspection & Test Method Validation:
  • Define Receiving Inspection requirements.
  • Validate test methods in alignment with internal Healthcare procedures.
• Cross-Functional Collaboration:
  • Work with cross-functional teams to develop and implement product acceptance sampling strategies.
  • Deploy supplier quality tools such as PFMEA, MSA, control plans for both new and legacy products.
• Technical Support & Quality Assurance:
  • Provide technical assistance to suppliers throughout the product/process qualification lifecycle.
  • Ensure delivery of high-quality parts, materials, and services to prevent defects and support Healthcare's commitment to reliability.
• Issue Resolution:
  • Collaborate with suppliers to address SCAPA/Client issues in compliance with company standards.

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 4+ years of experience in supplier quality engineering within the medical device industry.
• ISO 13485 Certified Talent preferred by client.
• Strong knowledge of PPAP, IQ/OQ/PQ, PFMEA, MSA, and control plans.
• Familiarity with FDA and ISO 13485 standards.
• Excellent communication and problem-solving skills.
• Ability to work independently and in cross-functional teams.